Efficacy of Alphanate^® (Human Factor VIII/Von Willebrand Factor Concentrate) in Preventing Excessive Bleeding during Surgery or Invasive Procedures in Patients with Congenital Von Willebrand Disease. A Multicenter Retrospective Study.

Objective: To assess the efficacy of Alphanate® as replacement therapy in subjects with congenital VWD undergoing surgical or invasive procedures.

Methodology: Retrospective data from 5 hospitals and accounting for 8 years of chart review has been collected. The study protocol and the subject’s informed consent were approved by the local Institutional Review Boards. To date, 35 treated events (27 subjects) have been evaluated. Events were classified by local investigators and an independent referee committee as major or minor surgery, and invasive procedures. Treatment efficacy was rated using a 4-point verbal rating scale. Replacement therapy was considered effective if the treatment outcome was rated as excellent or good, and non-effective when the outcome was rated as poor or none.

Results: Efficacy results (number and percentage) obtained by local investigators and the referee committee are presented in Tables 1 and 2.

Conclusions: Since there may be bias in the interpretation of responses made by the participating physicians, it was felt that true responses might better be assessed retrospectively by an adjudication committee. Therefore, both Tables were presented here. Much of the discrepancies between these 2 tables was generated by oral surgery. There was a high level of efficacy agreement between investigators and the referree committee. Therefore, it is concluded that Alphanate® is effective in preventing excessive bleedings during surgeries and invasive procedures in subjects with congenital VWD.